G-6-PDH Deficient and Normal Control (2019-03-26)
- Starting date:
- March 26, 2019
- Posting date:
- April 9, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69548
Last updated: 2019-05-17
Affected Products
G-6-PDH Deficient and Normal Control
Reason
Randox is conducting a Field Safety Corrective Action for G6PDH Deficient and Normal Controls for the lots specified in the Field Safety Notice . The target values and ranges are incorrect and are re-assigned. In addition customers are reminded to follow the assay protocol for G6PDH in the Instructions for Use (PD410) and to use the quoted calibration factor to ensure accuracy of results.
Affected products
G-6-PDH Deficient and Normal Control
Lot or serial number
676PD
687PD
700PD
701PD
715PD
716PD
Model or catalog number
PD2617
PD2618
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Crumlin, County Antrim
BT29 4QY
UNITED KINGDOM